Safety and pharmacokinetics of CIGB-552

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Acronym of Public Title:

ARGOS-1

Scientific title:

Evaluation of the safety and pharmacokinetics and determining the maximum tolerable dose with the use of antitumor peptide CIGB-552 in solid tumors. Phase I.

Secondary indentifying numbers:

IG/CIGB-552I/TS/1301

Issuing authority of the secondary identifying numbers:

Center for Genetic Engineering and Biotechnology (CIGB)

Source(s) of monetary or material support:

Heber Biotec S.A., Cuba

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of Drugs, Medical Devices and Equipment (CECMED)

Reference number:

In process

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Braulio

Last name:

Mestre Fernandez

Medical Specialty :

1st grade Specialist in Oncology

Affiliation:

National Institute of Oncology and Radiobiology

Postal address:

Calle F esquina 29, Vedado

City:

Havana

Country:

Cuba

Zip Code:

10400

Telephone:

+53-78382576

+53-78382577

+53-78382578

Email address:

brauliofdez@infomed.sld.cu [1]

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Not applicable

Research ethics committees:

National Institute of Oncology and Radiobiology, January 17, 2014

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

15/09/2015

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Solid tumors

Intervention(s):

Study group (CIGB-552): The product will be repeated dose administered subcutaneously in 6 dose levels of scale: 1.4 mg, 2.8 mg, 4.7 mg, 7.0 mg, 9.8 mg and 13 mg. The appropriate dose is given three times a week for 2 weeks (6 doses).

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

Adverse events of intensity III and IV (Common Toxicity Criteria (Common Toxicity Criteria) (CTC) version 4.0 of the National Cancer Institute USA). Measuring time: after each administration, four weeks after the last administration of the product and at 12 weeks after inclusion.

Key secondary outcomes:

Safety - Adverse Events (AE). Measuring time: after each administration, 4 weeks after treatment and 12 weeks after inclusion. . Occurrence of EA (Yes, No) . Name of AE (description of the AE) . Duration of AE (time from start date until end date of AE) . Intensity of AE (Common Toxicity Criteria-CTC) . Gravity (Grave, Not serious) . Result (1. Recovered, 2. Improved, 3. Persists or Squeals) . Attitude respect to EA (1. Temporal interruption, 2. Definitive interruption, 3. Without change, 4. Other) . Causality relationship of AE (11. Very Likely / Safe, 2. Likely 3. Possible, 4. Unlikely 5. Not related, 6. Unknown) . Lot of antitumor peptide (lot identification) - Laboratory tests. Hematology (hemoglobin, Leucogram with differential, hematocrit, platelet count). Measuring time: at baseline, four weeks after treatment and at 12 weeks after inclusion. - Laboratory tests. Biochemistry (transaminases, glucose, bilirubin, alkaline phosphatase, creatinine, total and fractionated proteins). Measuring time: at baseline, four weeks after treatment and at 12 weeks after inclusion. - Laboratory tests. Immunology (CD4 and CD8 levels). Measuring time: at baseline, four weeks after treatment and at 12 weeks after inclusion. Tumor assessment -Objective response (RECIST criteria. Progression, Complete response, Partial response y stable disease, progression). Measuring time: 4 weeks after treatment and 3 months after inclusion. Pharmacokinetic - CIGB peptide plasma concentration-552, only three dose levels 2.8 mg, 4.7 mg y 9.8 mg. Measuring time: at baseline, 10, 20 and 40 minutes and at 1, 1.5, 3, 6, 12 and 24 hours after administration of the product

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

None

Inclusion criteria:

1) Age ≥18 years. 2) Patients who meet the diagnostic criteria. 3) Values normal blood glucose values according institucionales.l 4) General status ECOG 0-2. 5) Patients who have normal functioning of organs and bone marrow defined by the following parameters: - Haemoglobin ≥ 9 g / L. - Leukocytes ≥ 3 x 109 / L. - Absolute neutrophil count ≥ 1.5 x 109 / L. - Platelet count ≥ 150-250 x 109 / L. - Total bilirubin: Within normal limits as institutional values. - TGP and TGO ≤ 2.5 times the institutional upper limit of normal. - Creatinine: Within normal limits as institutional values. 6) Voluntary patient by signing the informed consent model. 7) Life expectancy greater than 3 months.

Exclusion criteria:

1) Patients who are of childbearing potential not using adequate contraceptive method (IUDs, barrier methods, hormones or tubal ligation) for men (vasectomy, condom use) prior to their inclusion in the study and / or while participating in the clinical trial. 2) Patients with a positive pregnancy test, breastfeeding and postpartum women. 3) Patients suffering from severe allergic diseases. 4) diabetic patients. 5) That have been treated with other biological therapy six months preceding the date of inclusion.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Other

Other design:

Dose escalation

Phase:

Target sample size:

21-42

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Maria

Middle Name:

Acelia

Last Name:

Marrero Miragaya

Specialty:

Doctor of Medical Sciences

Affiliation:

National Coordinating Center for Clinical Trials (CENCEC)

Postal Address:

5ta A e/ 60 y 62 Miramar

City:

Havana

Country:

Cuba

Zip Code:

10600

Telephone:

(53-7)-2164221

Email :

acelia@cencec.sld.cu [2]

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Maribel

Last Name:

Guerra Vallespi

Specialty:

Doctor of Biological Sciences

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB)

Postal Address:

Ave. 31 e/ 158 y 190, Cubanacán, Playa

City:

Havana

Country:

Cuba

Zip Code:

10600

Telephone:

(53-7)-2504490

Email :

maribel.guerra@cigb.edu.cu [3]

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000196

Date of Registration in Primary Registry:

22/05/2015

Record Verification Date:

2015/05/22

Next update date:

2016/05/22

Link to the spanish version:

Click here [4]